FDA recall D-0531-2024

Product

EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01, NDC (sample lot) 61755-005-54

Reason for recall

Lack of Assurance of Sterility: Complaints of syringe breakage

Distribution

USA nationwide.

Key facts

Status

Terminated

Initiation date

2024-05-15

Report date

2024-06-05

Termination date

2025-09-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0531-2024